Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride

Dentin Hypersensitivity Clinical Trial

Official title:

Effectiveness of Using Nano-Silver Fluoride Varnish Versus Sodium Fluoride Varnish in Management of Cervical Dentin Hypersensitivity in Adult Patients: A Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04731766
• Other study ID #: 205
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient.

Description:

In-vivo part:

Each varnish will be applied separately on different teeth according to the manufacturer's instructions and the VAS will be measured according to a specific timeline: T0 (baseline, before application of varnish), T1 (1 week after application), T2 (4 weeks after application) and T3 (4 weeks after application).

In-situ part:

Dentin specimen will be prepared from extracted teeth from the orthodontic department in our college, sterilized and prepared.

it will be bonded to an orthodontic wire and bonded to upper first molar. Dentinal occlusion will be measured using scanning electron microscope following the same timeline.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients consulting in one of the Qasr Einy, faculty of dentistry outpatient clinics.

• Males or females.

• Patient's age range 25-50 years.

• Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bi-cuspids, and first molars with exposed cervical dentine) with teeth scoring Bpain (VAS score: greater than or equal to 3) during application of stimulus (airblast and tactile sensitivity test).

• Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3).

• Patients accept the 2-months follow-up period.

• Provide informed consent.

Exclusion Criteria:

• • Patients participating in another dental study that may alter the results of this study.

• A medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders).

• Any chronic medical condition that requires the regular use of anti-inflammatory pain medications.

• Patients used or applied a desensitizing varnish within the last four weeks.

• Patients with dental problems; chipped teeth, defective restorations, fractured Un-displaced cuspids or deep dental caries.

• Lack of patient's approval and compliance.

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Behavioral:
• Citrine 5 % sodium fluoride
Citrine varnish is a 5% sodium fluoride varnish, It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride.
• concocted nano-silver fluoride
Nano-silver fluoride (NSF) is a solution which has been introduced as an experimental formulation in which it's stability for three years has been proved by Santos et al. The laboratory synthesis of concocted NSF was carried out in a nano-technology center; Several trials were done until we have reached a successful end product.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nayera Hassanien Mohamed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in dentin Hypersensitivity	Visual Analogue Scale (VAS) will be used; 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity.	1 week, 4 weeks & 8 weeks
Secondary	change in dentinal Tubule Occlusion	the dentinal tubule occlusion of citrine 5% sodium fluoride and the dentinal tubule occlusion of nano-silver fluoride for treatment of dentin hypersensitivity and compare them together	1 week, 4 weeks * 8 weeks